UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035816
Receipt No. R000040747
Official scientific title of the study Comparative clinical & radiographic evaluation to assess the effect of platelet rich fibrin on peri implant wound healing & crestal bone levels-A randomized clinical trial
Date of disclosure of the study information 2019/02/08
Last modified on 2019/02/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Comparative clinical & radiographic evaluation
to assess the effect of platelet rich fibrin on peri implant wound healing & crestal bone
levels-A randomized clinical trial
Title of the study (Brief title) EFFECT OF PLATELET RICH FIBRIN ON PERI IMPLANT WOUND HEALING AND CRESTAL BONE LEVELS
Region
Asia(except Japan)

Condition
Condition partially edentulous patient in mandibular posterior region
Classification by specialty
Oral surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the crestal bone levels at mesial & distal aspects of dental implants placed along with platelet rich fibrin . To evaluate soft tissue healing following implants placed along with autologous platelet rich fibrin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Wound Healing Index (WHI) was recorded at baseline and after
second stage surgery that is at 3 months. Marginal Bone Levels (MBL) was assessed at baseline and re
evaluated and 6 months
Key secondary outcomes Ancillary parameters included Plaque index (PI),Bleeding Index
(BI),Pocket probing depth (PPD),Peri-implant attachment level (PAL).These were
recorded after placement of healing abutments at 3 and 6 months postoperatively.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 implant with platelet rich fibrin
Interventions/Control_2 implant without platelet rich fibrin
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <
Age-upper limit
55 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with adequate bone width, height & density to recieve an implant
2.Male and female patients belonging to age group 20 to 55years.
3.Systemically healthy patients.
4.patients with healthy periodontal status & bilaterally symmetrical occlusion.
Key exclusion criteria 1.Patients with conditions like Diabetes, hypertension, atherosclerosis and other systemic
diseases known to affect periodontal status.
2.Pregnant and Lactating Women.
3.Patients with deleterious habits like alcohol consumption , tobacco habits,smoking and any
other adverse habits.
4 Patients who have received any surgical or non surgical periodontal therapy in past 6
months.
5.Patients who have received any antimicrobial therapy in past 3 months.
Target sample size 10

Research contact person
Name of lead principal investigator Aakriti Sharma
Organization ITS Dental college,Hospital and Research centre,Greater Noida.
Division name department of periodontics & implantology
Address 47 Knowledge park III,greater noida, Uttar Pradesh,India
TEL 91-9811533651
Email aakriti8911@gmail.com

Public contact
Name of contact person Aakriti Sharma
Organization ITS Dental college,Hospital and research centre,Greater Noida
Division name department of periodontics & implantology
Address 47 knowledge park III,greater noida,Uttar Pradesh ,India
TEL 91-9811533651
Homepage URL
Email aakriti8911@gmail.com

Sponsor
Institute self founding
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization India

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions ITS dental college,hospital and research centre ,greater noida,uttar pradesh

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 08 Day

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 11 Month 11 Day
Anticipated trial start date
2016 Year 11 Month 11 Day
Last follow-up date
2018 Year 08 Month 07 Day
Date of closure to data entry
2018 Year 08 Month 07 Day
Date trial data considered complete
2018 Year 08 Month 07 Day
Date analysis concluded
2018 Year 10 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results Results of the study revealed improvement in all clinical parameters from baseline to 6 months
but no significant differences were observed in terms of wound healing undex, pocket probing depth and perimplant attachment levels. Ancillary parameters
like plaque index and bleeding index also showed significant improvements from baseline values.
Other related information Based on the inferences drawn from the present study it can be concluded that within the
limitations of this study, Platelet Rich Fibrin placed along with implants offers advantages for
patient comfort and accelerates the initial healing process. It allows better soft tissue maintenance and
favorable optimal bone regeneration.

Management information
Registered date
2019 Year 02 Month 08 Day
Last modified on
2019 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040747

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.